Safety Studies; Marketing Studies; Investigator led Studies; PTU/ATU Schemes
Many times, Companies will need to conduct safety studies (once a potential safety issue has been identified) or participate in Marketing Studies (Observational studies; Research Outcome Studies where safety data may be inadvertently captured) as well as Investigator Led Studies, all of which will require the Company to produce safety plans/protocols to ensure the safety data is properly captured and reported and PharSafer® have multi-national experience in making sure such plans and protocols can be successfully implemented and followed.
Compassionate Use/Named Patient Studies
PharSafer® has worked in many situations involving compassionate use programmes, either as extensions to clinical trial studies or for use during the products post-marketing phase in countries where licences have yet to be obtained.
There is a need for such programmes to follow the varied legislation in terms of safety monitoring and PharSafer® has multi-national experience of conducting very large compassionate use programmes including using such data as supportive data in further licence submissions.
Other Safety Provisions
PharSafer® has also written safety information for presentation to Independent Data Monitoring Committees (IDMC, DSMB) and has participated in open sessions to discuss safety information and has also contributed members to Companies for IDMC representation.
The use of Data Safety Monitoring Boards is critical in some product development programmes and PharSafer® has multi-national experience in the set up and maintenance of such activities including template Charters and SOPs to describe how the IDMC should operate.
Safety Review and Signal Detection
An essential part of any management of safety involves safety review, whether this is for generic products, over the counter, herbal products or new chemical entities.
Part of the regular and routine safety assessments that are performed in safety review are the cumulative safety data reviews by product to ensure that there are no new safety signals requiring analysis, quantification, amendments to labelling; benefit-risk revisions or the implementation of Risk Management Plans.
PharSafer® has many years of experience in signal detection and safety review for many different types of products, both clinical and post-marketing.
PharSafer® uses a number of techniques to enhance and determine new safety signals and changes in Benefit-Risk (B/R) for client products in order to maintain patient safety and ensure Regulatory compliance.
Records of all safety reviews are approved, signed by PharSafer® and the client and maintained for possible Regulatory Inspector review.
Risk Management Plans (RMPs) & Risk Evaluation Mitigation Strategy (REMS)
Most products submitted for licence approval in the European Union (EU) will require a Risk Management Plan. This document which also fits into the Company approach to pharmacovigilance is mentioned in the DDPS and forms part of the CTD in section 1.8.2.
PharSafer® have and do provide RMPs for clients for a range of products including biologics; new chemical entities; new product combinations; new formulations and generics as well as design the plans and follow their execution, submission, approval and monitoring as part of licence approval.
PharSafer® has submitted over 30 of these for various Companies and have either had the RMPs approved or successfully argued that no additional activities (other than routine surveillance) was required for marketing to commence.
Additionally, PharSafer® has worked with the production and use of REMS, the FDA equivalent of RMPs in Europe. Although similar there are subtle differences but by co-ordination of these activities to streamline efficiency the client Company can achieve the safety goals and satisfy Regulatory requirements.